Effect of an exercise-based cardiac rehabilitation program “Baduanjin Eight-Silken-Movements with self-efficacy building” for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial

BACKGROUND Exercise-based cardiac rehabilitation is a beneficial therapy for patients with chronic heart failure. The delivery of exercise-based cardiac rehabilitation should adopt an evidence-based approach, as well as be culturally appropriate and sensitive to individual needs and preferences. The Baduanjin Eight-Silken-Movements with Self-efficacy Building for Heart Failure (BESMILE-HF) program is the first to apply a traditional Chinese exercise, Baduanjin, as the core component in an exercise-based cardiac rehabilitation program. This trial aims to assess the efficacy, safety, and acceptability of the addition of the BESMILE-HF program to usual medications for patients with chronic heart failure. METHODS/DESIGN The BESMILE-HF study is a mixed-design study. It includes a two-group, parallel, randomized controlled trial with 200 chronic heart failure patients, as well as a qualitative component. Patients will be randomized into either an intervention group receiving the 12-week BESMILE-HF program plus usual medications, or a control group receiving only usual medications. The primary outcomes are peak oxygen consumption assessed using a cardiopulmonary exercise test, and disease-specific quality of life using the Minnesota Living with Heart Failure Questionnaire. The secondary outcomes are: exercise performance, exercise self-efficacy, general quality of life, dyspnea and fatigue, depression, cardiac function, prognostic and inflammatory indicator levels, hospitalization, use of medications, and major adverse cardiac events. Assessments will be carried out at baseline, and at the 4th week, 8th week, and 12th week. The qualitative component will include a semi-structure interview describing patients' experiences with the intervention. DISCUSSION This study can provide evidence for how to deliver a contextually adapted exercise-based cardiac rehabilitation program with the potential to be scaled up throughout China. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03180320 . Registered on 2 June 2017.